Even as the Drugs and Cosmetics Act is not yet ready with a penal provision to punish entities for illegal clinical trials, the Centre has conceded before the Supreme Court that at least 80 people have lost their lives due to such trials in the last seven years.

Pointing out that the ministry of health was trying to get the ?deficiency? relating to the penal provisions removed by replacing the old law with a 2013 amendment Bill, the Centre said it intended to table the amendments in the Budget session of Parliament.

In an affidavit submitted as per the Supreme Court?s directive, the ministry has said that Serious Adverse Events (SAEs) of deaths during the clinical trials between 2005 and 2012 have been 2,644, out of which 80 were attributable to clinical trials. Other deaths could be due to illness and diseases. There were around 12,000 incidents of other side-effects of trials and 506 of these were pertained to clinical trials directly. Payments have been made in 44 cases of deaths, up to 2011, the affidavit stated.

A bench headed by Justice RM Lodha had slammed the Centre for failing to stop the ?racket? of uncontrolled clinical trial of drugs on humans causing deaths.

Observing that the government has slipped into a ?deep slumber?, stopping just a step short of banning all clinical trials until the Centre had a proper regulatory framework, the court made it clear that the secretary will be ?personally responsible? for any aberration.

The ministry in its new affidavit said that a new rule has been inserted in the Act, expanding the responsibilities of the sponsor (entity directly involved in conducting the trial), investigator and Ethics Committee, and to ensure payment of compensation in cases and deaths and injury of subjects within three months.

While compensation will have to be paid in cases of deaths and injuries to the subjects, the new rule will also require a sponsor or its representatives to provide free medical treatment as long as required in cases of other SAEs due to botched-up clinical trials. The format of the consent form will also be amended to ensure maximum knowledge of the regulations and remedial measures to the subjects and his representatives, it added.